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Effects of a Seven-day BASIS™ Supplementation on Menopausal Syndromes and Measurements of the Urinary Vitamin B3 and Estradiol Levels in Pre-, Peri- and Post-menopause

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04841499
Recruitment Status : Completed
First Posted : April 12, 2021
Last Update Posted : November 18, 2021
Sponsor:
Collaborator:
Elysium Health, Inc.
Information provided by (Responsible Party):
University of South Alabama

Brief Summary:
The purpose of this study is to determine whether a short supplementation (7days) with BASIS™ increases the natural production of estradiol, measured in urinary waste. The overall objective is to determine whether through increased estradiol levels, the undesirable menopausal effects, assessed via questionnaires, are mitigated by a short-term supplementation with BASIS™

Condition or disease Intervention/treatment Phase
Menopause Drug: BASIS™ (Crystalline Nicotinamide Riboside 250mg and Pterostilbene 50mg) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Seven-day BASIS™ Supplementation on Menopausal Syndromes and Measurements of the Urinary Vitamin B3 and Estradiol Levels in Pre-, Peri- and Post-menopause
Actual Study Start Date : April 5, 2021
Actual Primary Completion Date : July 15, 2021
Actual Study Completion Date : July 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Arm
7 days of BASIS™ orally
Drug: BASIS™ (Crystalline Nicotinamide Riboside 250mg and Pterostilbene 50mg)
take 2 capsules orally each day for 7 days




Primary Outcome Measures :
  1. Production of Estradiol [ Time Frame: 7 days ]
    To determine whether a short supplementation with BASIS™ impacts the natural production of estradiol, measured in urinary waste.

  2. Change undesirable effects of menopause [ Time Frame: 7 days ]
    To determine whether, through increased estradiol levels, the undesirable menopausal effects are impacted by a short-term supplementation with BASIS™.



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Biological female as determined at birth
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 35 years of age or older
  • pre, peri or post menopausal

Exclusion Criteria:

  • Less than 35 years of age
  • Hormone replacement therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04841499


Locations
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United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36604
Sponsors and Collaborators
University of South Alabama
Elysium Health, Inc.
Publications of Results:

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Responsible Party: University of South Alabama
ClinicalTrials.gov Identifier: NCT04841499    
Other Study ID Numbers: USAH-EH301
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: November 18, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of South Alabama:
pre menopause, peri menopause, post menopause, menopause, hot flashes, declining estradiol leves
Additional relevant MeSH terms:
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Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents